Bacteriotherapy in Pediatric Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT01757964|
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : May 25, 2016
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis CD||Biological: Bacteriotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bacteriotherapy in Pediatric Inflammatory Bowel Disease|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2015|
Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.
- Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring [ Time Frame: 2 weeks ]The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757964
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|